Rhinitis, Allergic, Perennial Clinical Trial
Official title:
A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)
Verified date | September 2017 |
Source | ALK-Abelló A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the
treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in
children and adults.
The primary hypothesis of this study is that administration of MK-8237, compared to placebo,
results in significant reduction in the average total combined rhinitis score (TCRS).
Status | Completed |
Enrollment | 1482 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: - History of AR/ARC to house dust of 1 year duration or more (with or without asthma) - If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study - Able to read, understand and complete questionnaires and diaries Exclusion Criteria: - Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen - History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed - Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis) - Received an immunosuppressive treatment within 3 months prior to screening - Unstable or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists [SABAs]) at any time within 3 months prior to screening - Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening - History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen - History of chronic urticaria and/or angioedema within 2 years prior to screening - History of chronic sinusitis during 2 years prior to screening - Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study - Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening - Previous exposure to MK-8237 - Receiving ongoing treatment with any specific immunotherapy at screening - Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine - Unable to meet medication washout requirements prior to screening - Unable or unwilling to comply with the use of self-injectable epinephrine - Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study - Likely to travel for extended periods of time during the efficacy assessment period - Participating in a different investigational study at any site during this study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
ALK-Abelló A/S | Merck Sharp & Dohme Corp. |
Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, Rehm D, Kaur A, Li Z, Lu S. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allerg — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment | The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. | Last 8 weeks of treatment (Weeks 44 to 52) | |
Primary | Number of Participants Who Experience At Least One Adverse Event (AE) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to 54 weeks | |
Primary | Number of Participants Who Discontinue Study Drug Due to an AE | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to 52 weeks | |
Secondary | Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment | The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. | Last 8 weeks of treatment (Weeks 44 to 52) | |
Secondary | Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment | The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. | Last 8 weeks of treatment (Weeks 44 to 52) | |
Secondary | Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment | The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. | Last 8 weeks of treatment (Weeks 44 to 52) | |
Secondary | Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment | Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores). | Last 8 weeks of treatment (Weeks 44 to 52) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02443805 -
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
|
Phase 3 | |
Completed |
NCT01231464 -
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis
|
Phase 3 | |
Completed |
NCT00232518 -
Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis
|
N/A | |
Completed |
NCT00224523 -
Long Term Safety Of GW685698X Via Nasal Biopsy
|
Phase 3 | |
Completed |
NCT00658918 -
To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)
|
Phase 3 | |
Completed |
NCT00404586 -
Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
|
Phase 1 | |
Withdrawn |
NCT02988778 -
Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis
|
Phase 3 | |
Completed |
NCT00988247 -
Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
|
Phase 3 | |
Completed |
NCT01678807 -
Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)
|
Phase 1 | |
Completed |
NCT01644617 -
A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627)
|
Phase 2 | |
Completed |
NCT01216384 -
Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers
|
Phase 1 | |
Completed |
NCT00848965 -
A Randomised, Double Blind, Placebo Controlled, 4 Period, Incomplete Block, Crossover Study Assessing the Dose-response Curve of Fluticasone Propionate in an Antigen Challenge Chamber
|
Phase 4 | |
Completed |
NCT00092118 -
The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
|
Phase 3 | |
Completed |
NCT00839189 -
Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults
|
Phase 1 | |
Completed |
NCT00570492 -
Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
|
Phase 4 | |
Completed |
NCT00806754 -
Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490)
|
Phase 4 | |
Recruiting |
NCT00153595 -
EWO1 in Persistent Allergic Rhinitis Patients
|
Phase 2/Phase 3 | |
Completed |
NCT00132925 -
An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis
|
Phase 3 | |
Completed |
NCT02498509 -
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
|
Phase 3 | |
Completed |
NCT01134705 -
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
|
Phase 3 |